Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
AstraZeneca
Fish and Richardson
Cipla
UBS
Colorcon
Dow
Mallinckrodt
Express Scripts

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091231

« Back to Dashboard

NDA 091231 describes PANTOPRAZOLE SODIUM, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Mylan Labs Ltd, Sandoz Inc, Exela Pharma Scs Llc, Actavis Totowa, Amneal Pharms, Apotex Inc, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Perrigo R And D, Sun Pharm Inds Ltd, Teva, Torrent Pharms, and Wockhardt, and is included in twenty-two NDAs. It is available from fifty-nine suppliers. Additional details are available on the PANTOPRAZOLE SODIUM profile page.

The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 091231
Tradename:PANTOPRAZOLE SODIUM
Applicant:Wockhardt
Ingredient:pantoprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091231
Mechanism of ActionProton Pump Inhibitors
Suppliers and Packaging for NDA: 091231
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 091231 ANDA Unit Dose Services 50436-8102 N 50436-8102-2
PANTOPRAZOLE SODIUM pantoprazole sodium TABLET, DELAYED RELEASE;ORAL 091231 ANDA WOCKHARDT LIMITED 55648-433 N 55648-433-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jan 19, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Jan 19, 2011TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Fish and Richardson
Baxter
Fuji
Cipla
Covington
Dow
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.